(252 days)
Silicone double loop ureteral stents:
The Silicone double loop ureteral stents are intended for adult and pediatric (children and adolescents) patients for drainage of the upper urinary tract over fistulas or ureteral obstacles and/or for healing of the ureter. These stents may remain implanted for up to 12 months.
Pyelostent and Stenostent Silicone double loop ureteral stents: Drainage of the upper urinary tract and/or ureter healing during management of ureteral stenosis:
For Pyelostent® Silicone double loop ureteral stents: Partial enlargement of the stent diameter, for localized stenosis of the ureteropelvic junction in adult and pediatric (adolescents) patients.
For Stenostent® Silicone double loop ureteral stents: Total enlargement of the stent diameter, for ureteral stenosis in adult and pediatric (children and adolescents) patients.
The Pyelostent® and Stenostent® Silicone double loop ureteral stents may remain implanted for up to 12 months.
The ImaJin Silicone double loop ureteral stent kit product family was originally cleared as Porges™ Silicone Double Loop Ureteral Stents in 510(k) K013921. The ImaJin Silicone double loop ureteral stent family consists of three single use, autostatic stents intended to drain the upper urinary tract and allow healing in case of ureteral obstacles or damage to the ureter. The Pyelostent and Stenostent Silicone double loop ureteral stents have partial and complete reinforcement along the straight catheter section respectively to add crush resistance. The devices are provided with a pusher and in some cases a guidewire. The Silicone double loop ureteral stents are ethylene oxide sterilized, single use, implantable devices.
The current submission is to update the indication for use statement, revise the Instructions for Use, add information on MRI compatibility, modify drainage hole size in some models, modify packaging, and modify the device performance specifications.
This document is an FDA 510(k) clearance letter for a medical device (ureteral stents). It does not contain information about the performance of an AI/ML device, nor does it provide the type of detailed study data requested for acceptance criteria and study proving device performance.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, ground truth, or MRMC studies from the provided text.
The document primarily focuses on:
- Confirming the substantial equivalence of the Coloplast stents to a previously cleared predicate device.
- Listing the indications for use.
- Detailing the types of non-clinical (mechanical/performance) testing performed, such as dimensional testing, flow rate, tensile strength, radiopacity, MRI safety, and sterilization validation. It explicitly states: "No animal studies or clinical testing were provided to support substantial equivalence between the subject and predicate devices."
This document is about traditional medical device clearance, not an AI/ML-driven diagnostic or assistive device.
§ 876.4620 Ureteral stent.
(a)
Identification. A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.(b)
Classification. Class II (performance standards).